Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

Part of paid clinical trials in St Louis, Missouri.

Sponsor
AB Science
Study ID
NCT01694277
Phase
PHASE3
Status
Completed

Conditions

  • Gastrointestinal Stromal Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Masitinib — DRUG
    12 mg/kg/day
  • Sunitinib — DRUG
    50 mg/day

Study Details

The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in the treatment of patients with gastro-intestinal stromal tumor (GIST) after progression with imatinib.

Key Dates

Start date
Apr 30, 2012
Status verified
Dec 2020
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020

Study Design

Enrollment
258 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Masitinib
    Participants receive masitinib (12 mg/kg/day), given orally twice daily.
  • Active Comparator: Sunitinib
    Participants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From day of randomization to death, assessed for a maximum of 60 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in St Louis, MO

By research site
Washington University School of Medicine· St Louis, MO

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